Pemigatinib + Pembrolizumab vs Pemigatinib Alone vs Standard of Care for Urothelial Carcinoma (FIGHT-205)

NCT ID: NCT04003610

Last Updated: 2025-11-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-14
• Study Completion Date: 2021-04-18

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of pemigatinib plus pembrolizumab or pemigatinib alone versus the standard of care for participants with metastatic or unresectable urothelial carcinoma who are not eligible to receive cisplatin, are harboring FGFR3 mutation or rearrangement, and who have not received prior treatment.

Conditions

Metastatic Urothelial Carcinoma; Unresectable Urothelial Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pemigatinib + Pembrolizumab

Combination of pemigatinib (13.5 milligrams \[mg\] once a day orally) plus pembrolizumab (200 mg every 3 weeks \[Q3W\] intravenously \[IV\])

Group Type: EXPERIMENTAL

Pemigatinib

Intervention Type: DRUG

13.5 mg once a day orally

Pembrolizumab

Intervention Type: DRUG

200 mg Q3W intravenously

Pemigatinib

Pemigatinib (13.5 mg once a day orally) alone

Group Type: EXPERIMENTAL

Pemigatinib

Intervention Type: DRUG

13.5 mg once a day orally

Standard of Care

Either gemcitabine plus carboplatin or pembrolizumab as standard of care. Gemcitabine 1000 mg/meters squared (m\^2) IV over 30 minutes on Days 1 and 8, followed by carboplatin (dosed to target area under the concentration-time curve \[AUC\] of 5 mg/milliliters \[mL\]/minute \[min\] or 4.5 mg/mL/min if required per local guidelines) on Day 1 or 2 of each 3-week cycle. Pembrolizumab 200 mg IV on Day 1 of each 21-day treatment cycle for up to 35 cycles or disease progression.

Group Type: ACTIVE_COMPARATOR

Gemcitabine

Intervention Type: DRUG

1000 mg/m\^2 IV over 30 minutes on Days 1 and 8 of each 3-week cycle

Carboplatin

Intervention Type: DRUG

Dosed to target AUC of 5 mg/mL/min or 4.5 mg/mL/min if required per local guidelines on Day 1 or 2 of each 3-week cycle

Interventions

Pemigatinib

13.5 mg once a day orally

Intervention Type: DRUG

Pembrolizumab

200 mg Q3W intravenously

Intervention Type: DRUG

Gemcitabine

1000 mg/m\^2 IV over 30 minutes on Days 1 and 8 of each 3-week cycle

Intervention Type: DRUG

Carboplatin

Dosed to target AUC of 5 mg/mL/min or 4.5 mg/mL/min if required per local guidelines on Day 1 or 2 of each 3-week cycle

Intervention Type: DRUG

Other Intervention Names

INCB054828; Keytruda®

Eligibility Criteria

Inclusion Criteria

• Histologically documented metastatic or unresectable urothelial carcinoma. Both transitional cell and mixed transitional cell histologies are allowed, provided urothelial component is ≥ 50%.
• At least 1 measurable target lesion per RECIST v1.1.
• Must be ineligible to receive cisplatin. Patients ineligible for any platinum-based chemotherapy are allowed.
• Known FGFR3 mutation or rearrangement confirmed by the central laboratory prior to randomization.
• Central laboratory test result of PD-L1 status is mandatory at screening.
• Have received no prior systemic chemotherapy for metastatic or unresectable urothelial carcinoma (except adjuvant platinum-based chemotherapy following radical cystectomy, with recurrence > 12 months from completion of therapy, or neo-adjuvant platinum-based chemotherapy, with recurrence > 12 months since completion of therapy).
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
• Willingness to avoid pregnancy or fathering children.

Exclusion Criteria

• Prior receipt of a selective FGFR inhibitor for any indication or reason.
• Prior receipt of an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another co-inhibitory T-cell receptor.
• Receipt of anticancer medications or investigational drugs for unresectable and/or metastatic disease.
• Concurrent anticancer therapy, except for treatment allowed per protocol.
• Has disease that is suitable for local therapy administered with curative intent.
• Has tumor with any neuroendocrine or small cell component.
• Current evidence of clinically significant corneal or retinal disorder as confirmed by ophthalmologic examination.
• Has received prior radiotherapy to a metastatic site without the use of chemotherapy radiosensitization within 3 weeks of the first dose of study treatment, with the exception of palliative radiotherapy to bone lesions, which is allowed if completed 2 weeks before the start of study treatment.
• Has central nervous system metastases, unless the participant has completed local therapy (eg, whole brain radiation therapy, surgery, radiosurgery) and has discontinued use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study.
• Known additional malignancy that is progressing or required active treatment within the past 3 years
• Laboratory values outside the protocol-defined range at screening.
• Clinically significant or uncontrolled cardiac disease.
• History of autoimmune disease that has required systemic treatment in past 2 years.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incyte Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luis Feliz Vinas, MD

Role: STUDY_DIRECTOR

Incyte Corporation

Locations

Hospital Puerta de Hierro

Majadahonda, , Spain

Hospital Universitario Virgen Del Rocio

Seville, , Spain

Marin Cancer Care

Greenbrae, California, United States

Christiana Care Helen F. Graham Cancer Center

Newark, Delaware, United States

Cotton-O'Neil Clinical Research Center, Hematology & Oncology

Marietta, Georgia, United States

Simmons Cancer Institute At Siu

Springfield, Illinois, United States

The University of Kansas Cancer Center

Westwood, Kansas, United States

Smhc Cancer Blood Disorders

Biddeford, Maine, United States

Summit Medical Group

Florham Park, New Jersey, United States

Mount Sinai School of Medicine

New York, New York, United States

Oregon Health & Science University

Portland, Oregon, United States

Charleston Hematology Oncology Associates

Charleston, South Carolina, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

The Center For Cancer and Blood Disorders

Fort Worth, Texas, United States

Onc Consultants Pharmacy 2

Houston, Texas, United States

Wilhelminenspital

Vienna, , Austria

Grand Hopital de Charleroi

Charleroi, , Belgium

Universitaire Ziekenhuis Leuven - Gasthuisberg

Leuven, , Belgium

Moncton Hospital - Horizon Health Network

Moncton, New Brunswick, Canada

Helsinki University Meilahti Tower Hospital

Helsinki, , Finland

Fonk Onkologian Klinikka

Tampere, , Finland

Turku University Hospital, Sct Unit

Turku, , Finland

Centre Hospitalier Universitaire de Besancon

Besançon, , France

Groupe Hospitalier Pellegrin Tripode

Bordeaux, , France

Polyclinique de Blois

La Chaussée-Saint-Victor, , France

Chu Nimes

Nîmes, , France

Groupe Hospitalier Pitie-Salpetriere

Paris, , France

Hopital Cochin Cancerologie

Paris, , France

Hopital Europeen Georges Pompidou (Hegp)

Paris, , France

Centre Hospitalier Universitaire de Poitiers

Poitiers, , France

Chu de Strasbourg Hopitaux Universitaires Service D Hematologie

Strasbourg, , France

Institut Claudius Regaud Oncopole Toulouse

Toulouse, , France

Kliniken Maria Hilf

Mönchengladbach, , Germany

University Hospital Waterford

Waterford, , Ireland

Iov - Istituto Oncologico Veneto Irccs

Bari, , Italy

Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari

Bari, , Italy

L AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA POLICLINICO S. ORSOLA � MALPIGHI

Bologna, , Italy

Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori

Meldola, , Italy

Fondazione Irccs Ca Granda Ospedale Maggiore

Milan, , Italy

Fondazione Irccs Istituto Nazionale Dei Tumori

Milan, , Italy

Ieo Istituto Europeo Di Oncologia Irccs

Milan, , Italy

Istituto Nazionale Tumori Fondazione Irccs G. Pascale

Napoli, , Italy

UNIVERSIT� CAMPUS BIO-MEDICO DI ROMA

Roma, , Italy

Irrcs Instituto Clinico Humanitas

Rozzano, , Italy

Azosp S.Maria Sc Oncologia

Terni, , Italy

Chiba University Hospital

Chiba, , Japan

Chiba Cancer Center

Chiba, , Japan

National Hospital Organization Kyushu Cancer Center

Fukuoka, , Japan

Saitama Medical University International Medical Center

Hidaka-shi, , Japan

Hirosaki University Hospital

Hirosaki-shi, , Japan

Hakodate Goryokaku Hospital

Hokkaido, , Japan

Sapporo Medical University Hospital

Hokkaido, , Japan

Nihon University Itabashi Hospital

Itabashi-ku, , Japan

Nara Medical University Hospital

Kashihara-shi, , Japan

St. Marianna University School of Medicine Hospital

Kawasaki-shi, , Japan

Kagawa University Hospital

Kita-gun, , Japan

Nho Shikoku Cancer Center

Matsuyama, , Japan

Toranomon Hospital

Minatoku, , Japan

Osaka International Cancer Institute

Osaka, , Japan

Saitama Medical Center Jichi Medical University

Saitama-shi, , Japan

Tohoku University Hospital

Sendai, , Japan

Jichi Medical University Hospital

Shimotsuke-shi, , Japan

Keio University Hospital

Shinjuku-ku, , Japan

Osaka University Hospital

Suita-shi, , Japan

National Cancer Center Hospital

Tokyo, , Japan

Toyama University Hospital

Toyama, , Japan

Olsztynski Osrodek Onkologiczny Kopernik

Olsztyn, , Poland

Champalimaud Foundation - Champalimaud Centre For the Unknown (Champalimaud Cancer Center)

Lisbon, , Portugal

Spitalul Clinic Judetean de Urgenta 'Sf Apostol Andrei' Constanta

Constanța, , Romania

Fakultna Nemocnica S Poliklinikou Zilina

Žilina, , Slovakia

Hospital Clinic I Provincial

Barcelona, , Spain

Ico Institut Catala D Oncologia

Barcelona, , Spain

Ico Girona

Girona, , Spain

Hospital Clinico San Carlos

Madrid, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Universitario de La Paz

Madrid, , Spain

Hospital Universitario Hm Sanchinarro

Madrid, , Spain

Hospital Clinico Universitario de Valencia

Valencia, , Spain

Barts Health Nhs Trust - St Bartholomews Hospital

London, , United Kingdom

Countries

United States; Austria; Belgium; Canada; Finland; France; Germany; Ireland; Italy; Japan; Poland; Portugal; Romania; Slovakia; Spain; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2019-000721-50

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

INCB 54828-205

Identifier Type: -

Identifier Source: org_study_id